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ProNervium Review: Can This East-Asian "Supernatural Fungus" Really Help With Neuropathy?

ProNervium is a nerve health supplement created by the Institute of Neuropathy.

Marketed to anyone with nerve pain – from diabetics to those with physical nerve damage – ProNervium claims to have helped 134,000+ people conquer nerve pain.

Keep reading to find out everything you need to know about ProNervium and how it works today in our review.

What is ProNervium?

ProNervium is a capsulated nutritional supplement built to target the root cause of neuropathy: neurite degeneration.

Whether dealing with diabetic neuropathy or mild pins and needles in the extremities, ProNervium aims to help using a blend of natural ingredients.

In fact, according to supplement creator the Institute of Neuropathy, ProNervium has helped 134,200+ people conquer nerve pain.

One customer featured on the official website claims to have "noticed a significant reduction in discomfort within the first few days," for example, while others have experienced life-changing results – like walking without a cane or wheelchair and driving for the first time in eight years within weeks of taking ProNervium.

ProNervium was developed by two doctors, including a Chinese neurologist named Dr. Zhang Wei and a British doctor named Dr. James Hamilton.

ProNervium is priced at $69 and backed by a 180-day moneyback guarantee.

Try ProNervium now and experience the difference!

ProNervium Benefits

Some of the benefits of ProNervium, according to the official website, include:

  • Rapidly relieve nerve pain
  • 100% success rate in clinical trial with 1,820 volunteers
  • Doctor-formulated supplement
  • Backed by 180-day satisfaction guarantee
  • Target the root cause of nerve pain: damaged nerves
  • No side effects
  • How Does ProNervium Work?

    ProNervium works by targeting the root cause of nerve pain: damaged nerves.

    To do that, ProNervium uses a blend of 10 mushroom extracts linked to neurite repair. These mushroom extracts work from the inside out to repair damaged areas of your nervous system, helping you enjoy lasting relief.

    ProNervium was created by a doctor named Dr. Hamilton, who appears to recommend it to anyone dealing with nerve pain – even the most severe and debilitating cases of nerve pain. Dr. Hamilton based his formula off the work of Dr. Zhang Wei, who has spent his career researching the effects of mushroom extracts on the nervous system.

    ProNervium appears to help with all types and severities of neuropathy. Maybe you have a mild tingling. Or, maybe your nerve pain is so severe that you rely on a wheelchair and cane to move around. Whatever the situation, you could experience lasting relief with ProNervium, according to the official website.

    Some ProNervium users featured on the official website, for example, appear to have been restricted to a wheelchair before taking ProNervium. Others struggled to walk or sleep because of their severe nerve pain. Many of these customers claim to have experienced lasting relief with ProNervium – often within just days.

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    Who Created ProNervium? About Dr. Hamilton & Dr. Wei

    ProNervium was created by a British doctor named Dr. James Hamilton, who specializes in anti-aging and neurology.

    Dr. Hamilton relied heavily on a Chinese doctor named Zhang Wei to create his nerve pain relief formula. Dr. Zhang Wei, in fact, recommended the first five ingredients in ProNervium, while Dr. Hamilton added the remaining five:

    Dr. Zhang Wei is a neurologist from Qingyuan, China. The city is known as "mushroom town" and is considered the "birthplace of fungal medicine."

    For centuries, practitioners in the region have used mushrooms as an alternative remedy for various medical conditions. Today, those healers continue to protect their mushroom formulas from outsiders, even using secret code to speak about ingredients.

    Dr. Hamilton discovered Dr. Wei's work and, after adding five new ingredients and testing 300 variations, Dr. Hamilton was confident he had created the world's ultimate nerve pain relief supplement.

    ProNervium Repairs Neurites to Repair Neuropathy

    The primary goal of ProNervium is to reverse neuropathy. To do that, ProNervium targets neurites, repairing and restoring neurites to provide lasting relief.

    Your nervous system and body are filled with neurites. When you're healthy, these neurites send signals from your body to your brain.

    Over time, however, physical injuries or conditions like diabetes can destroy neurites, causing you to feel numbness, tingling, or burning.

    Typically, doctors recommend nerve pain medication to help repair neurites and reduce pain signals. However, Dr. Hamilton and Dr. Wei, who helped create ProNervium, recommend using mushroom extracts instead.

    How Mushrooms Repair Nerves

    ProNervium contains mushrooms like cordyceps and lion's mane to promote nerve repair from the inside out.

    Dr. Hamilton and Dr. Wei, creators of ProNervium, selected all mushrooms based on their ability to promote neurite repair and create lasting relief from nerve pain.

    Here's how the mushroom extracts in ProNervium could promote nerve repair from the inside out, according to the official ProNervium website:

    Mushrooms are packed with antioxidants, including beta glucans and unique molecules like cordycepin.

    These molecules work throughout the body to promote nerve repair, support healthy inflammation, and boost overall nervous system health.

    When you have nerve pain, your neurites have been destroyed. You can see this effect on an X-ray: the X-ray shows dark areas of your body where you don't have neurites, leading to nerve pain.

    By taking certain mushroom extracts, you can target pain, inflammation, and nervous system health from the inside out, repairing neurites for lasting relief.

    Overall, mushrooms contain "neuritogenic compounds," according to the official ProNervium website, which leads to "reversing neuropathy."

    ProNervium Ingredients

    ProNervium contains a blend of doctor-selected mushroom extracts to promote nerve pain relief from the inside out. Each two capsule serving of ProNervium contains 1,330mg of total formula across 10 different mushroom extracts.

    Five of the mushrooms in ProNervium were chosen by Dr. Zhang Wei based on his experience with traditional medicine in China, where he works as a neurologist. An additional five ingredients were selected by Dr. James Hamilton, a British doctor and anti-aging specialist.

    Here are all of the active mushroom extracts in ProNervium and how they work:

  • Cordyceps Mushroom: There is 266mg of cordyceps sinensis powder extract (from the mycelium of the mushroom) in each serving of ProNervium, making it one of the four largest mushroom extracts in the formula. Cordyceps was the first mushroom ingredient recommended by Dr. Zhang Wei, the Chinese neurologist who helped to create ProNervium. Cordyceps is a "cure-all fungus," according to the official ProNervium website, because it's packed with an antioxidant called cordycepin that works by "rejuvenating the body inside and out." It can specifically promote neurite growth and repair.
  • Reishi Mushroom: There's also 266mg of reishi mushroom in each serving of ProNervium. It's one of the most important ingredients in ProNervium. The mushroom was originally selected by Dr. Zhang Wei, who descries it as a "supernatural fungus." It has a long history of use in traditional Chinese medicine. Formally known as Ganoderma lucidum, the mushroom can reduce discomfort "while exhibiting a strong neuroprotective effect," helping to target nerve pain today and in the future.
  • Shiitake Mushroom: Shiitake is one of the four largest mushroom extracts in ProNervium, with 266mg of shiitake mushroom in each serving. Shiitake was one of the five ingredients added by Dr. James Hamilton to Dr. Wei's original mushroom formula. Shiitake "is "effective in alleviating joint and muscle discomfort," according to the official ProNervium website, because it contains a molecule called lentinan linked to nerve regeneration.
  • Lion's Mane Mushroom: There's 266mg of lion's mane mushroom extract in each serving of ProNervium, making it one of the four largest mushroom extracts in the formula (along with the three mushrooms listed above). Formerly known as Hericium erinaceus, lion's mane mushroom is renowned for its pain relieving, neuroprotective effects. Some studies have shown lion's mane can specifically help with nerve cell growth and repair. As the official ProNervium website explains, lion's mane mushroom has "been shown to support the growth, survival, and restoration of nerve cells," making it a crucial ingredient in ProNervium.
  • Maitake Mushroom: Maitake is the first listed ingredient in the ProNervium proprietary blend (266mg per serving). It's one of six mushrooms in the blend. Because it's the first listed ingredient in the proprietary formula, there appears to be more maitake in ProNervium than any other active ingredient. Dr. Zhang Wei, who helped create ProNervium, refers to maitake as "dancing mushroom." The mushroom's healing properties were so legendary, according to Dr. Wei, that people used to dance when finding it in the forest. According to the official ProNervium website, maitake "promotes neurite regrowth."
  • Turkey Tail Mushroom: Turkey tail was one of the first ingredients added by Dr. James Hamilton to Dr. Wei's original mushroom formula. Turkey tail, according to Dr. Hamilton, contains beta glucans, polysaccharides, and triterpenoids to help with neuropathy discomfort. A 2017 study found turkey tail (Coriolus versicolor) extract improved exercise performance and reduced fatigue in mice, although no major studies have specifically analyzed the effects on the nervous system.
  • Chaga Mushroom: Chaga has been used for centuries in various remedies. It's particularly popular for digestive health and heart health. According to the makers of ProNervium, however, chaga can provide "amazing neuroprotective effects" while being rich in antioxidants, according to the official ProNervium website, helping to support cholesterol, boost cellular health, and promote immune function and blood pressure, among other benefits.
  • Sun Mushroom: ProNervium contains sun mushroom, a mushroom known for its anti-aging properties. It's one of five mushrooms added to ProNervium by Dr. Hamilton. Dr. Hamilton claims sun mushrooms work by "supporting nerve health and promoting healthy cellular regeneration." A 2024 sun mushroom study found sun mushrooms could magnify memory by boosting nerve growth.
  • White Button Mushroom: White button mushroom contains antioxidants to boost immune function and help with inflammation. Some studies show it stimulates the formation of blood vessels and helps with circulation. For many people, the root cause of nerve pain is poor circulation, and ProNervium aims to help. White button mushroom is one of the most common types of mushrooms in cooking and natural medicine.
  • Wood Ear Fungus: The final active ingredient in ProNervium is Auricularia auricula, or wood ear fungus. It's packed with polysaccharides linked to nerve regeneration. It can also promote cholesterol and heart health. The high polysaccharide content in ProNervium, according to the official website, is "crucial for nerve regeneration."
  • To refine the formula, Dr. Hamilton claims to have "tested over 300 ratios and weights." After all of this testing, he was confident he had created the ultimate mushroom remedy for joint pain.

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    How to Take ProNervium

    Dr. Hamilton recommends taking two capsules of ProNervium daily for a minimum of three to six months to reverse nerve pain and discomfort:

    Take 2 capsules of ProNervium daily with an 8oz glass of water

    For best results, continue to take ProNervium daily for 3 to 6 months

    Although Dr. Hamilton recommends taking the supplement for months, the supplement was shown to reverse nerve pain in 100% of participants within "weeks" of starting a clinical trial, according to the official website.

    How ProNervium Reverses Neuropathy: Benjamin Marsh Case Study

    One of the first people to take ProNervium was a retired sergeant named Benjamin Marsh.

    Benjamin Marsh also played a role in developing and marketing the formula – although the formula itself was created by Dr. Hamilton, who appears to have formal experience and qualifications in the field.

    Benjamin Marsh is 63 years old and lives in Boston with his wife, Mary. He wanted to reverse his neuropathy to help stay around for his wife, kids, and grandkids. However, doctor-prescribed neuropathy solutions weren't working for Benjamin.

    That's when Benjamin met Dr. Hamilton, who told him to take an early version of ProNervium. That formula quickly relieved Benjamin's severe neuropath, motivating the duo to sell the formula to customers worldwide.

    Here's what happened when Benjamin Walsh took ProNervium for the first time:

    Before taking ProNervium, Benjamin had a severe and debilitating case of neuropathy. It started a few years ago with slight numbness. Over time, it "felt like my feet, hands, legs and arms were on fire…24 hours a day," according to Benjamin.

    Benjamin's condition progressed to a point where he was unable to walk without a cane or wheelchair. He claims "walking without a walker, wheelchair or cane was impossible without nearly passing out from the discomfort." He couldn't drive a car.

    Benjamin tried to treat his nerve pain using various strategies. Two neurologists performed dozens of physicals and tests on Benjamin, for example. Benjamin went to a chiropractor. Nothing worked.

    Benjamin didn't diet or exercise. He simply started to take ProNervium daily.

    Within "a few hours" of taking his first dose of ProNervium, Benjamin "felt natural, powerful nutrition flowing through [his] veins."

    After taking ProNervium for four days, Benjamin was able to walk without his cane or wheelchair.

    After taking ProNervium for six days, Benjamin "started to feel the ground touch my foot again." His neuropathy had been so severe, he was unable to feel the ground with his feet. Benjamin noticed ProNervium had improved his balance and reduced the numbness and tingling, and stopped him from shaking.

    Within a few weeks of taking ProNervium each day, the supplement had "completely changed" Benjamin's life. He no longer felt nerve pain in his feet. He was able to drive for the first time in eight years. He claims it was "like [he] had a new life.

    To verify ProNervium had repaired Benjamin's nerves, Dr. Hamilton performed an X-ray scan on Benjamin's hands and feet. The X-ray showed Benjamin's "nerves almost completely recovered."

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    What to Expect After Taking ProNervium

    The makers of ProNervium claim to have conducted a clinical trial where 100% of participants reversed nerve pain within weeks of starting the trial – including people with diabetes, peripheral neuropathy, and other conditions.

    Here are some of the results you could experience with ProNervium, according to the clinical trial and the Institute of Neuropathy:

  • Reverse Nerve Pain & Discomfort: Your "constant nerve discomfort will vanish" after taking ProNervium, according to the official website. The supplement is marketed to people with all levels of nerve pain and discomfort – from debilitating nerve pain to mild tingling.
  • Target Even Severe Nerve Pain: According to the official website, the formula "is designed to rapidly relieve nerve discomfort in even the worst cases." Whether you're dealing with mild tingling or severe and debilitating nerve pain, you could experience rapid relief with ProNervium.
  • Improve Strength: According to the Institute of Neuropathy, "your arms and legs will regain strength" after taking ProNervium. Many diabetics and neuropathy sufferers lose strength because of the condition. When nerves get damaged, it's difficult to build strength in those areas of the body, causing muscles to atrophy.
  • Boost Mobility: When ignored over time, neuropathy can impede mobility. It can make it hard to walk without pain, for example. Many customers featured on the official ProNervium website appear to have improved mobility after taking the supplement – including some who previously used a wheelchair and were able to become more independent thanks to the supplement.
  • Starts Working Immediately: Typically, a doctor-recommended nerve repair treatment program takes a few weeks to provide noticeable benefits. However, ProNervium "starts working immediately," according to the official website. In fact, the manufacturer claims "once you take the first two capsules, the battle against neuropathy has already begun."
  • No Side Effects: According to the makers of ProNervium, the supplement is not linked to any side effects. The all-natural formula is soy-free, dairy-free, vegetarian, and non-GMO and completes extensive testing. In fact, the only reported side effect, according to the manufacturer is "having to toss your other [nerve pain] relievers in the trash."
  • Improve Sleep: After taking ProNervium, you'll enjoy "sleeping every night without having to get up ever hour because of discomfort," according to the manufacturer. Many nerve pain sufferers struggle with sleep because of their condition.
  • Avoid Canes, Wheelchairs, & Other Mobility Aids: Some neuropathy suffers struggle to walk unassisted. They need canes or wheelchairs for mobility. ProNervium can help you "walk and stand for hours without feeling discomfort…and without needing a cane or anyone's help," according to the manufacturer.
  • Throw Away Other Nerve Pain Relievers: Typically, doctors prescribe nerve pain medication to target and relieve the condition. However, Dr. Hamilton and his team claim you could "toss your other relievers in the trash" after taking ProNervium. Some people take supplements for nerve pain, while others take doctor-prescribed medication like gabapentin (Neurontin), pregabalin (Lyrica), duloxetine (Cymbalta), milnacipran (Savella), venlafaxine (Effexor), carbamazepine (Tegretol), or amitriptyline (Elavil).
  • Get your hands on ProNervium and experience the benefits now!

    ProNervium Clinical Trial

    Most nutritional supplement companies don't invest in clinical trials because they're expensive and not guaranteed to deliver the expected results.

    The Institute of Neuropathy was so confident in their formula, however, that they performed one of the largest trials in nerve pain supplement history, testing their supplement on a group of nearly 2,000 people.

    The trial had a stunning 100% success rate, helping "everyone" resolve nerve pain and discomfort.

    Here's how the ProNervium trial worked:

    The Institute of Neuropathy gathered a group of 1,820 volunteers.

    Some volunteers had medical conditions like diabetes. Others had peripheral neuropathy for other reasons. Volunteers had different intensities of discomfort – from debilitating pain to mild tingling.

    All volunteers received a multi-month supply of ProNervium.

    Within "weeks" of starting the trial, 100% of participants increased neurites from 400% to 900%.

    "The numbness, burning and tingling disappeared" in "every single person" in the trial, according to the Institute of Neuropathy. All participants were "able to walk normally again." Participants also improved sleep, strength, touch sensitivity, and more.

    The median nerve recovery was 67%. The best volunteers recovered 83% to 92% of their nerves, effectively reversing nerve pain completely.

    Even the world's best medications don't have a 100% success rate in clinical trials. The results of the Institute of Neuropathy trial on ProNervium were unlike anything seen before in the supplement space.

    Despite the incredible success of the ProNervium trial, the Institute of Neuropathy declined to publish it in a peer-reviewed medical journal. It's possible the organization was worried about backlash from pharmaceutical companies.

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    Scientific Evidence for ProNervium

    Can a nutritional supplement really repair nerves and reverse nerve pain? How does ProNervium work?

    First and most importantly, the makers of ProNervium claim to have conducted a large trial on ProNervium to verify it works. Although they didn't publish the trial in a peer-reviewed medical journal, they publish basic details about the trial at their official website – even claiming the formula had a 100% success rate and over 1,800 participants. As additional proof, the company cites 20+ studies published in peer-reviewed medical journals.

    To justify the use of lion's mane (Hericium erinaceous) mushroom extract, for example, the company cites one 2024 study showing lion's mane mushroom contains a natural ingredient called erinacine S that appears to promote "neuronal regeneration by inducing neurosteroids accumulation." ProNervium is specifically designed to promote nerve cell regrowth to help with neuropathy, and lion's mane mushroom extract has been shown to promote this effect in a genuine scientific study.

    Another study described lion's mane as a "medicinal mushroom" for its ability to modulate calcium signaling and murine nociceptive behavior, both of which were linked to nervous system health. The Institute of Neuropathy even cites one study where researchers found lion's mane mushroom extract significantly reduced neuropathic pain in mice with spinal nerve injuries.

    Many of the mushrooms in ProNervium work because they're packed with natural antioxidants. The Institute of Neuropathy cites one study published in the Journal of Ethnopharmacology, for example, showing Inonotus obliquus (chaga) mushroom extract exhibited significant anti-inflammatory and anti-nociceptive (pain relieving) effects.

    Cordyceps, another active ingredient in ProNervium, was linked to significant neurite outgrowth in a group of rats in a 2011 study. In that study, researchers exposed rats to cordyceps and found cordyceps significantly improved neurite activity, helping to protect against memory-related neuronal degeneration.

    Overall, ProNervium contains a blend of mushrooms linked to antioxidant, anti-inflammatory, and nerve repair effects across multiple studies. Those studies suggest ProNervium could help with nerve pain, although there's little evidence (outside of the large ProNervium clinical trial) that the supplement will reverse serious, debilitating nerve pain within weeks as suggested on the official website.

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    ProNervium Reviews: What Do Customers Say?

    The official ProNervium website has reviews from many participants who appear to have restored mobility, reversed nerve pain, and improved their quality of life significantly after taking ProNervium.

    Here are some of the reviews shared by verified purchasers on the official website:

    63-year old retired sergeant Benjamin Marsh reversed his debilitating nerve pain using ProNervium. Prior to taking the supplement, Benjamin hadn't driven a vehicle in eight years and was unable to walk without a cane or wheelchair. After taking the supplement, Benjamin completely reversed his condition within weeks, claiming he "regained 91% of [his] nerve function in just a few weeks," as verified by an X-ray scan.

    One customer was struggling with neuropathy "for 20 years" before taking ProNervium, describing the sensation as "unbearable." Medications provided temporary relief, but nothing seemed to last. After taking ProNervium, however, he noticed an "astonishing" difference: the supplement eliminated his neuropathy within a few weeks.

    One 63-year old described her neuropathy as "a daily battle" before she reversed her condition with ProNervium. She took multiple medications daily to manage her condition. After taking ProNervium, however, she "noticed a significant reduction in discomfort within the first few days." She no longer has a burning sensation, and she can "live [her] life without constantly being held back by neuropathy."

    One customer describes buying ProNervium as "the best decision of my life." She had previously tried multiple nerve pain supplements but nothing helped. After 30 days of taking ProNervium, however, she has "my life back."

    One customer "got rid of 100% of the discomfort, burning and tingling" after taking ProNervium for just 21 days.

    Some customers had debilitating, life-threatening nerve pain before rapidly reversing the condition with ProNervium. One customer claims he "spent more than 3 months in a wheelchair" thinking he was "going to die of so much discomfort" before he rapidly reversed his condition with ProNervium. Today, he claims he "can finally get out of bed without anyone's help and…can walk" thanks to the supplement.

    Overall, the Institute of Neuropathy claims to have helped 134,200+ people reverse neuropathy, restore mobility, and improve symptoms of nerve pain and discomfort.

    ProNervium Pricing

    ProNervium is priced at $69 per bottle. According to the Institute of Neuropathy, the company will eventually raise the price to $199 per bottle. However, you can pay $69 per bottle or less through a 2024 promotion.

    Here's how much you pay when ordering ProNervium online today:

  • 1 Bottle: $69
  • 3 Bottles: $177 ($59 Per Bottle) + Free Shipping
  • 6 Bottles: $294 ($49 Per Bottle) + Free Shipping
  • ProNervium is not available on Amazon or through GNC, Walgreens, or other retailers. It's exclusively available through the official Institute of Neuropathy website.

    Each bottle of ProNervium contains a 30-day supply, or 30 servings (60 capsules). You take two capsules daily for nerve pain relief.

    ProNervium Refund Policy

    All ProNervium purchases come with a 180-day, 100% satisfaction guarantee. You have 180 days to request a refund on ProNervium if you're unhappy for any reason.

    About the Institute of Neuropathy

    ProNervium was created by a UK-based supplement company named the Institute of Neuropathy. The organization worked with a British doctor named Dr. James Hamilton to create ProNervium. Dr. Hamilton based his formula partially off the work of a Chinese neurologist named Dr. Zhang Wei.

    The Institute of Neuropathy is based in London, although the company manufactures supplements in FDA-registered, GMP-certified facilities in the United States. The company was founded with the goal of "enhancing golden years with premier nutritional support."

    You can contact the Institute of Neuropathy and the ProNervium customer service team via the following:

    Email: support@instituteofneuropathy.Com

    Mailing Address: 71-75 Shelton Street, Covent Garden, London, WC2H 9JQ, UK

    As of 2024, ProNervium appears to be the first and only supplement created by the Institute of Neuropathy. There are no other products or services listed on the official website.

    Final Word

    ProNervium is a nerve pain relief formula marketed to people with all types of neve pain – from diabetic neuropathy to severe and debilitating peripheral neuropathy and everything in between.

    The supplement was created by a British doctor named Dr. James Hamilton, who based his formula off an ancient Chinese mushroom remedy created by Dr. Zhang Wei. After 300 different variations of the formula and a clinical trial involving 1,800+ participants, Dr. Hamilton is confident he has created one of the world's best nerve pain relief remedies.

    To learn more about ProNervium and how it works or to buy the nerve pain relief supplement online today, visit the official website.


    FDA Recognizes Fibromyalgia As A 'Serious Condition' And Fast-Tracks New Drug Candidate

    This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. With financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

    CHATHAM, NJ / ACCESSWIRE / August 1, 2024 / When it comes to chronic pain conditions, fibromyalgia is among the most common, afflicting more than ten million people in the United States. Globally, 3-6% of the world's population suffers from this chronic disease that has no cure. While it is more prevalent in women, men and children across every race can also be afflicted with fibromyalgia.

    With so many people suffering from a disease that brings widespread pain, fatigue and cognitive issues, it's no wonder the market for symptom treatment has seen steady growth over the years and is poised for more. By 2031, the fibromyalgia treatment market is projected to reach $3.86 billion growing at a CAGR of 3.3% between now and then.

    Fibromyalgia is a Serious Disease

    This form of chronic pain has become such a problem in the United States that the Food & Drug Administration (FDA) considers the disease to be a serious condition, which means it is a disease associated with morbidity that has a substantial impact on day-to-day functioning. After all, 70% of sufferers have difficulty with daily activities, 90% report poor sleep quality and 20% file disability claims.

    Most treatments on the market today are a combination of medication and self-care focused on reducing symptoms and improving the quality of life. Unfortunately, due to dissatisfaction with the available treatment options, many patients (at the direction of their medical providers) turn to opioids to relieve their pain. As it stands, more people diagnosed with fibromyalgia are prescribed opioids than the bestselling FDA-approved drug duloxetine (generic Cymbalta). That's concerning, given opioids can be addictive and with time, life-threatening.

    Of patients prescribed opioids for chronic pain, 21% to 29% misuse them while an average of 8% to 12% develop opioid use disorder. A U.S. Policy to address opioid use, which killed more than 100,000 Americans in 2022, is aimed at curtailing imports of fentanyl and synthetics. Many experts believe a concurrent and perhaps more effective strategy is to provide pain sufferers relief with non-addictive products.

    Fast Track Granted to TNX-102 SL*

    The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia. Tonix says the designation validates that fibromyalgia is a serious condition and that TNX-102 SL, which has no known addictive properties, has the potential to address this unmet medical need.

    The FDA's Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially get new treatments to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development.

    "The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options," said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. "If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years."

    TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity, setting it apart from existing treatments, which fail to manage sleep disturbances that exacerbate fibromyalgia symptoms, the company says.

    In recent Phase 3 trials, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.

    New Drug Application Coming Soon

    In addition to receiving Fast Track status, Tonix announced it is making progress on its new drug application (NDA), which it plans to submit to the FDA in the second half of this year. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding the application for TNX-102 SL.

    Tonix plans to request Priority Review designation for TNX-102 SL, and if granted, the FDA may accelerate the review of the new drug application.

    "The NDA being prepared supports TNX-102 SL's potential position as a first-line non-addictive therapy for fibromyalgia, indicated for long-term daily use at bedtime," said Lederman.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    Featured photo by B-Me on Pixabay

    Click here for more information on Tonix Pharmaceuticals:https://redingtonvirtual.Com/tnxp-aw-2408/

    Investor ContactJessica MorrisTonix Pharmaceuticalsinvestor.Relations@tonixpharma.Com(862) 904-8182

    SOURCE: Tonix Pharmaceuticals Holding Corp.

    View the original press release on accesswire.Com

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    Tonix Pharmaceuticals Holding Corp.: FDA Recognizes Fibromyalgia As A 'Serious Condition' And Fast-Tracks New Drug Candidate

    This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. With financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

    CHATHAM, NJ / ACCESSWIRE / August 1, 2024 / When it comes to chronic pain conditions, fibromyalgia is among the most common, afflicting more than ten million people in the United States. Globally, 3-6% of the world's population suffers from this chronic disease that has no cure. While it is more prevalent in women, men and children across every race can also be afflicted with fibromyalgia.

    image

    With so many people suffering from a disease that brings widespread pain, fatigue and cognitive issues, it's no wonder the market for symptom treatment has seen steady growth over the years and is poised for more. By 2031, the fibromyalgia treatment market is projected to reach $3.86 billion growing at a CAGR of 3.3% between now and then.

    Fibromyalgia is a Serious Disease

    This form of chronic pain has become such a problem in the United States that the Food & Drug Administration (FDA) considers the disease to be a serious condition, which means it is a disease associated with morbidity that has a substantial impact on day-to-day functioning. After all, 70% of sufferers have difficulty with daily activities, 90% report poor sleep quality and 20% file disability claims.

    Most treatments on the market today are a combination of medication and self-care focused on reducing symptoms and improving the quality of life. Unfortunately, due to dissatisfaction with the available treatment options, many patients (at the direction of their medical providers) turn to opioids to relieve their pain. As it stands, more people diagnosed with fibromyalgia are prescribed opioids than the bestselling FDA-approved drug duloxetine (generic Cymbalta). That's concerning, given opioids can be addictive and with time, life-threatening.

    Of patients prescribed opioids for chronic pain, 21% to 29% misuse them while an average of 8% to 12% develop opioid use disorder. A U.S. Policy to address opioid use, which killed more than 100,000 Americans in 2022, is aimed at curtailing imports of fentanyl and synthetics. Many experts believe a concurrent and perhaps more effective strategy is to provide pain sufferers relief with non-addictive products.

    Fast Track Granted to TNX-102 SL*

    The FDA has granted Tonix Pharmaceuticals (NASDAQ:TNXP) a fully integrated biopharmaceutical company Fast Track designation for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), its drug candidate for the management of fibromyalgia. Tonix says the designation validates that fibromyalgia is a serious condition and that TNX-102 SL, which has no known addictive properties, has the potential to address this unmet medical need.

    The FDA's Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially get new treatments to patients sooner. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development.

    "The designation underscores the importance of addressing the unmet needs of fibromyalgia patients, who report dissatisfaction with current treatment options," said Seth Lederman, M.D., CEO of Tonix Pharmaceuticals. "If approved by the FDA, we expect TNX-102 SL to become the first new pharmacotherapy for fibromyalgia in over 15 years."

    TNX-102 SL is a sublingual formulation of cyclobenzaprine hydrochloride designed to improve sleep quality rather than quantity, setting it apart from existing treatments, which fail to manage sleep disturbances that exacerbate fibromyalgia symptoms, the company says.

    In recent Phase 3 trials, TNX-102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablet under the tongue.

    New Drug Application Coming Soon

    In addition to receiving Fast Track status, Tonix announced it is making progress on its new drug application (NDA), which it plans to submit to the FDA in the second half of this year. Coming out of pre-NDA meetings, Tonix said it is aligned with the FDA regarding the application for TNX-102 SL.

    Tonix plans to request Priority Review designation for TNX-102 SL, and if granted, the FDA may accelerate the review of the new drug application.

    "The NDA being prepared supports TNX-102 SL's potential position as a first-line non-addictive therapy for fibromyalgia, indicated for long-term daily use at bedtime," said Lederman.

    *TNX-102 SL is an investigational new drug and has not been approved for any indication.

    Featured photo by B-Me on Pixabay

    Click here for more information on Tonix Pharmaceuticals:https://redingtonvirtual.Com/tnxp-aw-2408/

    Investor ContactJessica MorrisTonix Pharmaceuticalsinvestor.Relations@tonixpharma.Com(862) 904-8182

    SOURCE: Tonix Pharmaceuticals Holding Corp.

    View the original press release on accesswire.Com






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